The Use of Cooling Helmet for Neuroprotection Management in Patient Undergoing Open Heart Surgery: an Evaluation of Postoperative Neuron-specific Enolase (NSE) and Delirium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Neuron-specific enolase
研究概览
简要总结
To know the relationship between the use of cooling helmet with the changes of NSE level and postoperative delirium event in open heart surgery
详细描述
Subjects were assigned into two groups after giving consent to participate in the study using random allocation, 13 subjects per group. Blood sample from CVC were obtained to assess NSE preoperative. After induction, cooling helmet with circulating cold water were placed on patients group A and without circulating cold water on group B. Blood samples were obtain again 6 hours after cardiopulmonary bypass off to assess NSE postoperative. Delirium was assessed using Confusion Assessment Method - Intensive Care Unit (CAM-ICU)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing their first open heart surgery using cardiopulmonary bypass
- •Age ≥18 year-old
- •Patient with American Society of Anesthesiologists (ASA) III
- •Patient with Glasgow Coma Scale (GCS) 15, fully aware and oriented
- •Patient fluent in Indonesia
排除标准
- •Patients did not give consent to participate in the study
- •Patients with central nervous system disease (stroke, intracranial tumor)
- •Patients with psychiatric problem (schizophrenia, depression)
- •Patients with cognitive problem
- •Blind and deaf patient
- •Patient on psychotrophic or narcotics medication
- •Drop out criteria
- •Surgery without cardiopulmonary bypass
- •Patient demise after surgery
- •Patients decided to refrain from the study
结局指标
主要结局
Neuron-specific enolase
时间窗: 6 hours post cardiopulmonary bypass off
Neuronal injury marker. The higher the value, the worse the outcome
Confusion Assessment Method - Intensive Care Unit (CAM-ICU)
时间窗: Changes of CAM-ICU from 12 hours to 24 hours postoperative
Tools to assess delirium. The higher the errors, the worse the outcome
次要结局
未报告次要终点
研究者
Mohamad Prakoso Adji
Principal Investigator
Indonesia University